Data / Medical devices / South Korea / Osung MND Co., Ltd.
Osung MND Co., Ltd.: FDA-registered device maker in Gimpo-si Gyeonggi, South Korea, 1 510(k) clearance
Osung MND Co., Ltd. is registered with the FDA (registration 9616119) in Gimpo-si Gyeonggi, South Korea. It lists 67 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 16, 1984. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9616119
- FEI number
- 3001032747
- Address
- 57, Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si Gyeonggi, South Korea, 10048
- Owner or operator
- OSUNG MND CO., LTD. (10023032)
- Roles
- Manufacturer
- First device listed
- November 1, 2007
- Registered through
- 2026
- Brand names listed
- 001 801 009, 001 801 018, 001.12M1, 001.14M1, 001.16M1, 001.18M1, 001.19C1, 001.19C2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Articulators | EJP | 1 | Manufacturer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Manufacturer | accessdata.fda.gov |
| Bone Particle Collector | MXP | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Burnisher, Operative | EKJ | 1 | Manufacturer | accessdata.fda.gov |
| Carrier, Amalgam, Operative | EKI | 1 | Manufacturer | accessdata.fda.gov |
| Carver, Dental Amalgam, Operative | EKH | 1 | Manufacturer | accessdata.fda.gov |
| Carver, Wax, Dental | EIK | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Manufacturer | accessdata.fda.gov |
| Condenser, Amalgam And Foil, Operative | EKG | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Periodontic | EMS | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Manufacturer | accessdata.fda.gov |
| Excavator, Dental, Operative | EKC | 1 | Manufacturer | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Manufacturer | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Manufacturer | accessdata.fda.gov |
| File, Margin Finishing, Operative | EKA | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Articulation Paper | EFK | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Manufacturer | accessdata.fda.gov |
| Frame, Rubber Dam | EJE | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Hemostat, Surgical | EMD | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Cutting, Operative | EKD | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Margin Finishing, Operative | EJZ | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Periodontic | EMO | 1 | Manufacturer | accessdata.fda.gov |
| Mallet | HXL | 1 | Manufacturer | accessdata.fda.gov |
| Marker, Periodontic | EMP | 1 | Manufacturer | accessdata.fda.gov |
| Measurer, Gingival Fluid | JEO | 1 | Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Manufacturer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Manufacturer | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Manufacturer | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Manufacturer | accessdata.fda.gov |
| Punch, Biopsy, Surgical | EME | 1 | Manufacturer | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Manufacturer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Manufacturer | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Manufacturer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Manufacturer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Manufacturer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Manufacturer | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 1 | Manufacturer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Suction Operatory | EBR | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| July 16, 1984 | K842006 | CITOJECT CARTRIDGE SYRINGE | EJI | Substantially Equivalent | Miles Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of File, Margin Finishing, Operative
- All makers of Forceps, Articulation Paper
- All makers of Punch, Biopsy, Surgical
- All makers of Instrument, Filling, Plastic, Dental
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Bone Particle Collector
Updated July 16, 1984. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.